NAMs for Medical Devices: Use of New Approach Methodologies for the Biological Safety Assessment of Medical Devices

Join New Approach Methodology Use for Regulatory Application (NURA) on December 2 to learn how you can use the latest in vitro methods for Biological Safety Assessment of medical devices. Engage with industry experts and the Center for Devices and Radiological Health and learn how to use new approaches for risk assessment in the ISO 10993 series, including updates to ISO 10993-01, ISO10993-10, and ISO 10993-23.

Speaker

Rose-Marie Jenvert, PhD SenzaGen
In Vitro Skin Sensitization Testing: Updates in ISO 10993-10, Validation and Regulatory Acceptance